Verona Coronary Physiology Interventional Registry

NCT ID: NCT07186582

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-14
• Study Completion Date: 2034-12-31

Brief Summary

The Verona Coronary Physiology Interventional Registry (VR-CP) is an observational study that collects information on patients with suspected coronary artery disease who underwent coronary angiography with a functional assessment of coronary stenoses. These functional tests include fractional flow reserve (FFR) or angiography-derived FFR, which help physicians understand whether a narrowing in the coronary arteries is likely to reduce blood flow to the heart.

The main goal of the study is to investigate whether the functional severity of coronary lesions is associated with future cardiovascular events, such as heart attack, the need for repeat procedures, or cardiovascular death. Additional objectives are to compare invasive FFR with angiography-derived FFR, to evaluate how these values relate to angina symptoms, and to analyze differences between patients treated conservatively with medications and those treated with coronary interventions.

The study is retrospective and single-center, including approximately 1,000 patients who underwent coronary physiology testing between 2010 and 2024 at the University Hospital of Verona. Follow-up information is obtained through review of medical records, outpatient visits, or telephone contacts, and patients will be followed for up to 10 years.

By combining detailed coronary physiology data with long-term clinical outcomes, this registry aims to improve understanding of which patients are at higher risk and to guide future strategies for the diagnosis and treatment of coronary artery disease.

Detailed Description

Coronary artery disease (CAD) remains one of the leading causes of morbidity and mortality worldwide. Conventional coronary angiography is limited because it shows the anatomy of the vessels but does not always reveal whether a narrowing truly reduces blood flow. To address this limitation, physiological indices such as fractional flow reserve (FFR) and angiography-derived FFR have been developed to provide a more accurate assessment of the functional severity of coronary stenoses.

The VR-CP registry is designed to evaluate the long-term prognostic value of these functional measurements. Patients who underwent coronary angiography with physiology testing at the University Hospital of Verona are included, and their angiographic data are linked to subsequent clinical outcomes. Follow-up information is collected through hospital records, outpatient visits, and telephone contacts, with a focus on major cardiovascular events and patient-reported angina status.

This study provides a unique opportunity to analyze a large, consecutive cohort over a long observation period. By correlating physiological lesion characteristics with outcomes such as myocardial infarction, target vessel revascularization, cardiovascular death, and quality-of-life measures, the registry aims to identify high-risk patient subgroups and refine treatment strategies.

The knowledge gained from this registry may contribute to more personalized decision-making in patients with CAD, improve the use of physiology in daily practice, and ultimately guide strategies for balancing conservative management versus invasive revascularization.

Conditions

Coronary Artery Disease; Ischemic Heart Disease (IHD); Coronary Heart Disease (CHD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Study cohort

The VR-CP study cohort includes consecutive adult patients (≥18 years) who underwent coronary angiography for suspected ischemic heart disease and had at least one coronary lesion assessed by fractional flow reserve (FFR) or angiography-derived FFR.

Coronary physiology assessment using Fractional Flow Reserve (FFR) as per standard of care and angiography-derived FFR

Intervention Type: DIAGNOSTIC_TEST

Functional assessment of coronary lesions performed using invasive FFR or angiography-derived FFR during coronary angiography as part of routine clinical care. No active intervention or treatment is assigned by the study.

Interventions

Coronary physiology assessment using Fractional Flow Reserve (FFR) as per standard of care and angiography-derived FFR

Functional assessment of coronary lesions performed using invasive FFR or angiography-derived FFR during coronary angiography as part of routine clinical care. No active intervention or treatment is assigned by the study.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Undergoing coronary angiography with functional assessment by FFR or angiography-derived FFR (index procedure)
• Willing and able to provide informed, written consent
• Age ≥ 18 years at the time of the index procedure

Exclusion Criteria

• Impossibility to obtain informed consent
• Age < 18 years at the time of the index procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: lead

Responsible Party

Roberto Scarsini

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Scarsini, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Universitaria Integrata Verona (AOUI)

Simone Fezzi, MD

Role: STUDY_CHAIR

AOUI Verona

Flavio Ribichini, MD

Role: STUDY_CHAIR

AOUI Verona

Locations

Azienda Ospedaliera Universitaria Integrata Verona(AOUI)

Verona, VR, Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

VR-CP

Identifier Type: -

Identifier Source: org_study_id